FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
125257–125280 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 1990
CARDIOVISTA
K902486 · DSH
Cardionostics, Inc.
Cardiovascular · 80d
Cleared Aug 23, 1990
LAKE MALE EXTERNAL CATHETERIZATION KIT
K902508 · FCM
Lake Medical Products, Inc.
Gastroenterology & Urology · 79d
Cleared Aug 23, 1990
MORTARA INSTRUMENT MODEL ELI 50
K902652 · DRT
Mortara Instrument, Inc.
Cardiovascular · 69d
Cleared Aug 23, 1990
COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC
K902758 · DQA
Cobe Laboratories, Inc.
Anesthesiology · 59d
Cleared Aug 23, 1990
A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE.
K902889 · DTD
Biotronik, GmbH & Co.
Cardiovascular · 52d
Cleared Aug 23, 1990
TESLACON (MAGNETIC RESONANCE DIAGNOSTIC DEVICE)
K902933 · LNH
General Electric Co.
Radiology · 51d
Cleared Aug 23, 1990
OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)
K902954 · HFC
Permobil AB
Obstetrics & Gynecology · 49d
Cleared Aug 23, 1990
IL THYROXINE (T4) ASSAY SYSTEM
K903095 · KLI
Instrumentation Laboratory CO
Chemistry · 41d
Cleared Aug 23, 1990
IMX B12
K903218 · LIG
Abbott Laboratories
Chemistry · 31d
Cleared Aug 23, 1990
PROLAX DISPOSABLE LATEX GLOVES (EXAM) HYPOALLERGEN
K903350 · LYY
Prolax Medical Products, Inc.
General Hospital · 29d
Cleared Aug 23, 1990
PROLAX DISPOSABLE LATEX GLOVES (EXAMINATION)
K903352 · LYY
Prolax Medical Products, Inc.
General Hospital · 28d
Cleared Aug 23, 1990
LIQUICHEK CK/LD ISOENZYME CONTROL
K903430 · JJT
Bio-Rad
Chemistry · 23d
Cleared Aug 23, 1990
ARIES TAPERSEAL(TM) SHEATH
K903442 · DYB
Aries Medical, Inc.
Cardiovascular · 23d
Cleared Aug 22, 1990
STEAMLINE
K895910 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 316d
Cleared Aug 22, 1990
METRICARE EMPTY CONTAINER SYSTEMS
K895922 · LHI
Metrix Co.
General Hospital · 315d
Cleared Aug 22, 1990
MULTI DOPPLEX, MD-1
K900882 · JAF
Huntleigh Technology, Inc.
Radiology · 177d
Cleared Aug 22, 1990
MER MULTIPLANE RECTAL PROBE (MRP)
K901033 · IYO
Medical Equipment Resources
Radiology · 169d
Cleared Aug 22, 1990
MER MULTIPLANE VAGINAL PROBE (MVP)
K901142 · HGL
Medical Equipment Resources
Obstetrics & Gynecology · 163d
Cleared Aug 22, 1990
NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM
K901263 · FOZ
Navion Biomedical Corp.
General Hospital · 159d
Cleared Aug 22, 1990
MODIFIED FREEMAN ACETABULAR CUP
K902110 · KWA
Turnkey Intergration USA, Inc.
Orthopedic · 105d
Cleared Aug 22, 1990
MODIFIED FREEMAN REVISION ACETABULAR CUP
K902111 · KWA
Turnkey Intergration USA, Inc.
Orthopedic · 105d
Cleared Aug 22, 1990
STANBIO CSF/URINE TOTAL PROTEIN TEST SET
K902204 · JIR
Stanbio Laboratory
Chemistry · 98d
Cleared Aug 22, 1990
ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS
K902298 · BSJ
Rondex Products, Inc.
Anesthesiology · 92d
Cleared Aug 22, 1990
ULTRA-VU ANGIOSCOPE
K902329 · LYK
Angiolaz, Inc.
Cardiovascular · 90d